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FDA 510(k)

Spinery™ RF Ablation System

K-Number: K223303 · 2023-08-30

ApplicantAxon Spine Medical System
Decision Date2023-08-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Spinery™ RF Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Axon Spine Medical System. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K223303. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spinery™ RF Ablation System?

Spinery™ RF Ablation System is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Axon Spine Medical System. The 510(k) number is K223303.

When did Spinery™ RF Ablation System receive FDA 510(k) clearance?

Spinery™ RF Ablation System received FDA 510(k) clearance on 2023-08-30, under 510(k) number K223303.

Who is the listed applicant for Spinery™ RF Ablation System?

The FDA 510(k) record lists Axon Spine Medical System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spinery™ RF Ablation System?

The FDA product code for Spinery™ RF Ablation System is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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